We are currently looking for Quality Engineers with experience in the medical device, pharmaceutical, biotechnology, or other regulated industries. The ideal candidate will have a strong understanding of quality systems, regulatory requirements, and manufacturing/validation processes.
Bachelor's degree in Engineering, Life Sciences, Pharmacy, or a related field.
0-2 years of experience in Quality Engineering/Quality Assurance.
Experience in medical devices, pharma, biotech, or another regulated industry.
Knowledge of CAPA, Client, deviations, change control, validation, audits, and quality systems.
Strong communication, analytical, documentation, and problem-solving skills.
Support quality activities related to manufacturing processes, products, and equipment.
Review and maintain quality documentation, SOPs, work instructions, and quality records.
Support CAPA, Client/deviations, root cause analysis, and corrective actions.
Participate in process validation, equipment qualification, and change control activities.
Support internal and external audits and ensure compliance with applicable regulatory requirements.
Work with Engineering, Manufacturing, R&D, and Quality teams to identify and resolve quality issues.
Ensure compliance with GMP/cGMP, FDA 21 CFR, ISO 13485, and other applicable standards.
Assist with continuous improvement and maintain strong documentation and data integrity practices.
Numbers & Facts
Location
North Andover, MA
Skills
Analysis Skillsunmatched
Biologyunmatched
Biotech and Pharmaceuticalunmatched
Change Controlunmatched
Code of Federal Regulationsunmatched
Communication Skillsunmatched
Continuous Improvementunmatched
Corrective Actionunmatched
Corrective and Preventative Action (CAPA) Systemsunmatched
Current Good Manufacturing Practice (cGMP)unmatched
Data Qualityunmatched
Documentationunmatched
Equipment Validationunmatched
External Auditunmatched
FDA (Food and Drug Administration)unmatched
GMP (Good Manufacturing Practices)unmatched
ISO (International Organization for Standardization)unmatched
Internal Auditunmatched
Maintain Complianceunmatched
Manufacturingunmatched
Manufacturing/Industrial Processesunmatched
Medical Equipmentunmatched
Pharmacyunmatched
Problem Solving Skillsunmatched
Process Validationunmatched
Quality Assuranceunmatched
Quality Engineeringunmatched
Quality Managementunmatched
Quality System Requirements (QSR)unmatched
Regulatory Complianceunmatched
Regulatory Requirementsunmatched
Research & Development (R&D)unmatched
Root Cause Analysisunmatched
Standard Operating Procedures (SOP)unmatched
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